FDA Authorizes Novel Robotic Blood Draw Device

The U.S. Food and Drug Administration (FDA) announced that it has granted Vitestro de novo authorization for Aletta, its standalone robotic device that can draw blood from the hands without intervention from a hands-on operator.

Once a trained phlebotomist initiates the session, Aletta autonomously performs the blood draw while the phlebotomist remains available to address any issues. The patient is guided to position their arm and starts the procedure by pressing a button. Aletta then uses near-infrared light and Doppler ultrasound to identify a suitable vein and distinguish it from arteries; if no appropriate vein is found, the device doesn’t proceed.

After identifying a vein, Aletta autonomously performs the remaining steps, including tourniquet application, skin preparation, needle insertion and disposal, tube changes, and bandaging. A supervising phlebotomist verifies tube order and fill levels after the draw.

One phlebotomist can oversee up to three Aletta devices at the same time, which Vitestro hopes can help address the current U.S. phlebotomist shortage.

Patient safety features include continuous skin disinfection during scanning, professional cleaning between patients, and automatic needle detachment if excessive movement occurs. Onboard sensors can also pause the procedure and alert the supervisor to unsafe conditions.

FDA authorization was supported by clinical data showing Aletta achieved blood draw success rates comparable to or better than trained phlebotomists across a diverse patient population, including those with difficult vein access and varying skin tones. Device-related adverse events were uncommon and mild, the agency said.

“This authorization reflects the FDA’s commitment to advancing innovative medical devices that help meet a critical public health need while maintaining the safety and effectiveness patients deserve,” said Michelle Tarver, M.D., Ph.D., Director of the FDA’s Center for Devices and Radiological Health. “Blood draws are one of the most commonly performed medical procedures in the United States, yet patients may face delays due to a growing shortage of trained phlebotomists.”

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